Duloxetine D/R…

Date

July 1, 2026

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Ongoing

Filed by

Direct Rx

Product

DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.

Reason

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Distribution pattern

U.S. Nationwide

Quantity

263 Bottles

Codes and lots

Lot: a) 09JA2530, 31JA2507, expires: 04/30/2027; b) Lot: 09DE2412, 09JA2528, 29JA2511, expires: 04/30/2027.

Recall started

June 22, 2026

Recall number

D-0617-2026

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-0617-2026. The agency record governs; check it and the company before acting.